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Completed

NCT Number: NCT06237673

The "CAD-Man" EXTEND Study

CAD-Man Extend is the long-term follow-up (clinical, laboratory, and computed tomography (CT) imaging) of a single-center, randomized, controlled CAD-Man trial comparing a CT-first strategy with a direct- invasive coronary angiography (ICA) diagnostic and management strategy, in 329 patients clinically referred for ICA with atypical angina or chest pain.

Overall goal:

The extension of CAD-Man follow-up (clinical, laboratory, and CT imaging) to approximately 10 years will provide the opportunity to compare plaque burden with CT-guided management versus direct-ICA at long-term and other endpoints.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

About this study

The CAD-Man (Coronary Artery Disease Management with Multislice Computed Tomography and Magnetic Resonance Imaging in Patients with Atypical Angina Pectoris) trial evaluated whether computed tomography (CT) or invasive coronary angiography (ICA) should be performed in patients clinically referred for coronary angiography with an intermediate probability of coronary artery disease. Patients with suspected CAD were randomized 1:1 ratio to CT, followed by ICA if positive for obstructive CAD, or to direct ICA. In both tests, obstructive CAD was defined as at least a 50% diameter stenosis in the left main coronary artery or at least a 70% diameter stenosis in other coronary arteries. Investigators and participants were blinded to randomization sequence but could not be blinded to the assigned group because of the apparent differences between CT and ICA. Independent investigators, who were blinded to the randomization group and were not part of the study team, anonymously assessed outcomes. Results on the comparative effectiveness of CT and ICA in preventing the primary outcome of major procedural complications within 48 hours of the last procedure and major adverse events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) were published for a median follow-up of 3.3 years.

The primary results and additional subgroup analyses of the CAD-Man trial led to three new hypotheses that will be evaluated in the CAD-Man Extend study.

  • Main hypothesis:

Whether CT-guided management of patients with atypical angina results in a reduction in coronary plaque burden (as determined by repeat CT scan) compared with direct-ICA management until 10 years.

  • Secondary hypothesis:
  • Whether clinical characteristics or blood levels and lipid-lowering medications have an impact on intraindividual progression of coronary plaques in patients in the CT group.
  • Whether primary CT examination in patients with atypical angina leads to a reduction in chronic impairment of renal function after 10-years compared with initial ICA examination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with suspected CAD
  • Patients with atypical angina
  • Patients who have previously participated in the CAD-Man study and have not died at a median follow-up of 3.3 years.

Exclusion criteria

Exclusion criteria

for additional CT scan:

  • Pregnancy
  • Any health condition that would cause concern that participation would not be in the best interest of health (eg, extensive comorbidities)

Treatment and study plan

CT

Diagnostic Test

CT-directed clinical management strategy

invasive coronary angiography (ICA)

Diagnostic Test

Standard clinical management directed by conventional invasive coronary angiography (ICA).

Primary outcomes

  1. Comparison of coronary plaque burden (non-calcified plaque volume (NCPV) measured by CT at 10-years between the initial randomization CT and ICA groups

    Time frame: at 10 years

  2. Comparison of coronary plaque burden total plaque volume (TPV)) measured by CT at 10-years between CT and ICA groups

    Time frame: at 10 years

Secondary outcomes

  1. Intraindividual progression of coronary artery disease (defined as change in coronary plaque burden from the first CT until the CT examination after 10 years) in the CT group.

    Time frame: at 10 years

  2. Comparison of the difference in chronic kidney injury, (eGFR and as increase in creatinine by 25% or 0.5 mg/dl) in both groups at 10-year follow-up between CT and ICA groups.

    Time frame: at 10 years

Other outcomes

  1. To compare minor cardiovascular events at final follow-up (after approximately 10 years).

    Time frame: at 10 years

    Cardiovascular events (unstable angina pectoris, re-revascularization, and first revascularization at least 2 months after randomization)

  2. To compare the cost-effectiveness in both groups. (after 10 years).

    Time frame: at 10 years

    To compare cost-effectiveness in both groups using the quality-adjusted life year data, and cost data derived from the trial.

  3. Comparison of two types of structured reports one medical and one using easy language (according to the german clinical practice guidelines) using patient acceptance questionnaire.

    Time frame: at 10 years

  4. To compare cholesterol level (LDL, HDL, Triglycerin) between the initial randomization CT and ICA groups.

    Time frame: at 10 years

  5. Comparison of statin use (proportion) between the initial randomization CT and ICA groups.

    Time frame: at 10 years

  6. Effect of statins on coronary plaque burden (non-calcified plaque volume (NCPV) )measured by CT at 10-years in CT group

    Time frame: at 10 years

  7. Effect of statins on coronary plaque burden (total plaque volume (TPV)) measured by CT at 10-years in CT group

    Time frame: at 10 years

  8. To compare calcified plaque volume at 10-years between CT and ICA group

    Time frame: at 10 years

  9. To compare low-attenuation plaque volume (LAPV) at 10-years between CT and ICA group

    Time frame: at 10 years

  10. To compare percentage atheroma volume (PAV) at 10-years between CT and ICA group

    Time frame: at 10 years

  11. To compare relative plaque volume at 10-years between CT and ICA group

    Time frame: at 10 years

  12. To compare segment stenosis score (SSS) at 10-years between CT and ICA group

    Time frame: at 10 years

  13. To compare segment involvement score (SIS) at 10-years between CT and ICA group

    Time frame: at 10 years

  14. To compare stenosis at 10-years between CT and ICA group

    Time frame: at 10 years

    Stenosis (no stenosis, <20%, 20 to 50%, >50%)

  15. To compare plaque composition at 10-years between CT and ICA group

    Time frame: at 10 years

    (calcified, non-calcified (fibrous, fibrofatty, lipid-rich), partially calcified)

  16. To compare high-risk plaque (HRP) features at 10-years between CT and ICA group

    Time frame: at 10 years

    (HRP; positive remodelling (PR), napkin ring sign, spotty calcification, low attenuation (LAP)

  17. To analyze the impact of baseline cardiovascular risk factors on non-calcified plaque volume (NCPV) in the CT Group

    Time frame: at 10 years

    Age (< 65, 65-75, > 75)

    Body Mass Index (BMI) (< 25, 25-30, > 30) Gender (male versus female) Diabetes (yes/no)

  18. To analyze the impact of baseline cardiovascular risk factors on total plaque volume (TPV) in the CT Group

    Time frame: at 10 years

    Age (< 65, 65-75, > 75)

    Body Mass Index (BMI) (< 25, 25-30, > 30) Gender (male versus female) Diabetes (yes/no)

  19. To analyze the impact of nutrition on non-calcified plaque volume (NCPV) in the CT Group

    Time frame: at 10 years

  20. To analyze the impact of nutrition on total plaque volume (TPV) in the CT Group

    Time frame: at 10 years

  21. To analyze the impact of physical activity (Freiburg questionnaire) on non-calcified plaque volume (NCPV) in the CT Group

    Time frame: at 10 years

  22. To analyze the impact of physical activity (Freiburg questionnaire) on total plaque volume (TPV) in the CT Group

    Time frame: at 10 years

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

A Randomized, Controlled Trial in Patients With Suspected Coronary Artery Disease Based on Acute or Chronic Atypical Angina Pectoris - EXTEND

Acronym: CAD-Man-EXTEND

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 1, 2024
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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